3. ? V?voj jednoho l¨¦ku v sou?asnosti stoj¨ª p?ibli?n¨§ jednu miliardu eur
? Jenom ka?d? t?et¨ª l¨¦k vr¨¢t¨ª investice vlo?en¨¦ do jeho v?zkumu
? Investice farmaceutick¨¦ho pr?myslu do procesu VaV jsou pr?m¨§rn¨§ 16 %
z tr?eb, co? je o mnoho vy??¨ª pod¨ªl ne? v jin?ch pr?mysln?ch odv¨§tv¨ªch
(0,3% v pr?myslu a 9,8 % v oblasti IT)
? Obdob¨ª od z¨¢kladn¨ªho v?zkumu, kdy v¨§dci zkoumaj¨ª 5 000 a? 10 000
molekul, a? po uveden¨ª l¨¦ku na trh, trv¨¢ pr?m¨§rn¨§ 12 let
? Proces v?zkumu a v?voje origin¨¢ln¨ªho l¨¦ku je nesm¨ªrn¨§ n¨¢kladn?, ale tak¨¦
riskantn¨ª a cenu selh¨¢n¨ª je mo?n¨¦ vy?¨ªslit a? na 75% z celkov¨¦ sumy
vlo?en¨¦ do VaV.
Zdroj: SAFS
3
4. ? Investice farmaceutick?ch spole?nost¨ª jsou v¨¢zan¨¦ na velmi dlouh¨¦
?asov¨¦ obdob¨ª
? N¨¢vratnost investic na v?zkum a v?voj je pro existenci farmaceutick?ch
spole?nost¨ª nevyhnuteln¨¢ z pohledu investov¨¢n¨ª do dal?¨ªch inovac¨ª
Jak¨¦ mo?nosti financov¨¢ni v?zkumu a v?voje
existuj¨ª v ?R?
4
5. Financov¨¢n¨ª v?zkumu a v?voje
? P?¨ªm¨¢ podpora: Granty, Dotace
? Administrativn¨§ n¨¢ro?n? a zdlouhav? proces
? Nutnost vej¨ªt se do konkr¨¦tn¨ªho programu a jeho podm¨ªnek
? Spole?nost nev¨ª zda grant z¨ªsk¨¢
? Nep?¨ªm¨¢ podpora, tzv. da¨¾ov¨¢: Od?itateln¨¢ polo?ka na VaV
? Spole?nost m??e uplatnit na ve?ker¨¦ projety VaV
? M¨¢ jistotu, ?e kdy? podm¨ªnky spln¨ª, z ¨²levy profitovat bude
? Administrativn¨§ m¨¦n¨§ n¨¢ro?n? proces
5
8. Od?itateln¨¢ polo?ka na VaV
OD?ITATELN? POLO?KA NA V?ZKUM A V?VOJ
S ¨²?innost¨ª od 1. 1. 2005 byla do z¨¢kona ?. 586/1992 Sb., o dan¨ªch z p?¨ªjm?
dopln¨§na ustanoven¨ª ¡ì34 odst. 4 a 5, podle kter?ch m??e poplatn¨ªk uplatnit
odpo?et od z¨¢kladu dan¨§ z p?¨ªjm? ve v??i 100 % v?daj? vynalo?en?ch p?i
realizaci projekt? v?zkumu a v?voje.
? Ustanoven¨ª umo?¨¾uje ode?¨ªst n¨¢klady vynalo?en¨ª na v?zkum a v?voj od
da¨¾ov¨¦ho z¨¢kladu dvakr¨¢t a uspo?it tak 19% z v?daj? vynalo?en?ch na
v?zkum a v?voj ve fisk¨¢ln¨ªm roce 2010.
? Od?itateln¨¦ n¨¢klady nemaj¨ª z¨¢konem limitovanou maxim¨¢ln¨ª horn¨ª hranici.
? Ustanoven¨ª umo?¨¾uje tak¨¦ spole?nostem ve ztr¨¢t¨§ profitovat z da¨¾ov¨¦
¨²levy a p?en¨¦st ji do dal?¨ªch 3 let.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
9. Od?itateln¨¢ polo?ka na VaV
V?po?et ¨²spory
Okam?it¨¢ ¨²spora
P?ED UPLATN?N?M ODPO?TU 190,000 K? z
Zdaniteln¨¦ p?¨ªjmy CZK 20 000 000 ka?d¨¦ho milionu
Da¨¾ @ 19% CZK 3 800 000 vynalo?en¨¦ho na
VaV
PO UPLATN?N? ODPO?TU
V?daje na VaV CZK 10 000 000
Zdaniteln¨¦ p?¨ªjmy CZK 10 000 000
Da¨¾ @ 19% CZK 1 900 000
?SPORA CZK 1 900 000
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
10. Od?itateln¨¢ polo?ka na VaV
Osobn¨ª v?daje Provozn¨ª v?daje Certifikace v?sledk?
? Mzdy ? Materi¨¢l ? Patenty
? Povinn¨¦ z¨¢konn¨¦ odvody ? Energie ? Certifikace
? Telekomunika?n¨ª poplatky
Odpisy R?zn¨¦
? Odborn¨¢ literatura
? Odpisy hmotn¨¦ho movit¨¦ho majetku
? Cestovn¨ª n¨¢hrady
? Odpisy nehmotn¨¦ho majetku
? Drobn? majetek, z¨¢soby
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
11. Od?itateln¨¢ polo?ka na VaV
Neuplatniteln¨¦ n¨¢klady
? Slu?by obecn¨§ a licen?n¨ª poplatky.
? Nehmotn¨¦ v?sledky v?zkumu a v?voje po?¨ªzen¨¦ od jin?ch osob.
? S v?jimkou v?daj? vynalo?en?ch na certifikaci v?sledk? VaV.
? N¨¢klady na n¨¢jemn¨¦, reprezentaci, konzultace, poradenstv¨ª a informa?n¨ª
servis, extern¨ª vzd¨§l¨¢v¨¢n¨ª, ¨²?ast na konferenc¨ªch v?etn¨§ cestov¨¦ho.
? V?daje na administrativn¨ª a ostatn¨ª podp?rn¨¦ ?innosti.
? ?innosti finan?n¨ª, person¨¢ln¨ª, IT, mana?ersk¨¦, opravy, p?epravn¨¦, atd.
? V?daje ji? podpo?en¨¦ z ve?ejn?ch zdroj?.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
12. Od?itateln¨¢ polo?ka na VaV
Ve?ejn¨¢ podpora
? Odpo?et nelze uplatnit na ty v?daje VaV, na kter¨¦ byla i jen z ?¨¢sti
poskytnuta podpora z ve?ejn?ch zdroj?.
? V p?¨ªpad¨§, ?e projekty podporovan¨¦ z ve?ejn?ch zdroj? jsou financov¨¢ny
pod¨ªlov¨§, tj. ka?d? jednotliv? n¨¢klad souvisej¨ªc¨ª s dan?m projektem je
z ur?en¨¦ ?¨¢sti financov¨¢n z ve?ejn?ch prost?edk?, ve?ker¨¦ takto
podpo?en¨¦ n¨¢klady projektu je nutn¨¦ p?i stanoven¨ª odpo?tu od dan¨§
vylou?it.
? D¨¢le je nutn¨¦ vylou?it ty jednotliv¨¦ v?daje, kter¨¦ jsou sice zahrnuty
v nepodpo?en?ch projektech v?zkumu a v?voje, ale jsou podpo?eny
?samostatn¨§¡° z ve?ejn?ch zdroj?.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
13. Od?itateln¨¢ polo?ka na VaV
Spole?nosti ve ztr¨¢t¨§
? Nelze-li odpo?et uplatnit v roce, kdy n¨¢rok na odpo?et vznikl z d?vodu, ?e
poplatn¨ªk:
? Vyk¨¢zal da¨¾ovou ztr¨¢tu.
? Z¨¢klad dan¨§ je ni??¨ª ne? odpo?et.
? Poplatn¨ªk m¨¢ mo?nost uplatnit nevyu?it? odpo?et nebo jeho zb?vaj¨ªc¨ª ?¨¢st
v nejbli??¨ªm zda¨¾ovac¨ªm obdob¨ª, nejv??e ve t?ech zda¨¾ovac¨ªch obdob¨ªch.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
14. Od?itateln¨¢ polo?ka na VaV
Po?ad¨ª od?itateln?ch polo?ek
? V z¨¢kon¨§ nen¨ª ur?eno po?ad¨ª polo?ek od?itateln?ch od z¨¢kladu dan¨§.
? Je na rozhodnut¨ª poplatn¨ªka, zda uplatn¨ª jako prvn¨ª odpo?et ztr¨¢ty nebo
odpo?et na u?n¨§ nebo b?val? re-investi?n¨ª odpo?et anebo odpo?et na
v?zkum a v?voj.
? Lh?ta pro uplatn¨§n¨ª odpo?tu na VaV je 3 roky.
? Lh?ta pro uplatn¨§n¨ª da¨¾ov¨¦ ztr¨¢ty je 5 let.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
15. Od?itateln¨¢ polo?ka na VaV
Projekt v?zkumu a v?voje
? Identifika?n¨ª ¨²daje o poplatn¨ªkovi.
? Doba ?e?en¨ª projektu.
? C¨ªle projektu.
? P?edpokl¨¢dan¨¦ celkov¨¦ v?daje na ?e?en¨ª projektu.
? Jm¨¦na a p?¨ªjmen¨ª osob, kter¨¦ budou odborn¨§ zaji??ovat ?e?en¨ª projektu.
? Zp?sob kontroly a hodnocen¨ª postupu ?e?en¨ª projektu a v?sledk?.
? Datum, m¨ªsto, jm¨¦no a p?¨ªjmen¨ª opr¨¢vn¨§n¨¦ osoby, kter¨¢ projekt
schv¨¢lila.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
16. Od?itateln¨¢ polo?ka na VaV
Obt¨ª?e p?i uplat¨¾ov¨¢n¨ª od?itateln¨¦ polo?ky na VaV
? Identifikace v?zkumu a v?voje.
? Vypracov¨¢n¨ª dokumentace.
? Identifikace n¨¢klad? na v?zkum a v?voj.
? Nedostate?n¨¢ znalost praxe da¨¾ov?ch org¨¢n?.
? Nedostate?n¨¢ znalost interpretace da¨¾ov?ch ustanoven¨ª.
? Nedostate?n¨¦ zdokumentov¨¢ni odpo?tu.
? Probl¨¦my s obh¨¢jen¨ªm odpo?tu p?i da¨¾ov¨¦ kontrole.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
18. Research and development
Basic research Applied research Development
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
19. Research and development
Basic Research
? Experimental or theoretical work undertaken primarily to acquire new
knowledge of the underlying foundation of phenomena and observable
facts
? Without any particular application or use in view
? It brings new insights that are not directly applicable
? Focused on a deeper and fuller understanding of new laws
? It answers the question WHY
? There is no immediate results, results occur only after many years
? It is often very expensive
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
20. Research and development
Applied research
? Original investigation undertaken in order to acquire new knowledge
? Directed primarily towards a specific practical aim or objective
? Searching for ways how to use the knowledge coming from basic
research
? Answers the question How?
? It is directly connected with the practice ¨C there are concrete outcomes
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
21. Research and development
Experimental Development
? Systematic work, drawing on existing knowledge gained from research
and/or practical experience directed to:
? Producing new materials, products or devices, to installing new
processes, systems and services,
? Improving substantially those already produced or installed
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
22. Research and development
The basic criterion for distinguishing R&D from related activities
? Presence of an appreciable element of novelty
? Resolution of scientific and/or technological uncertainty
When the solution to a problem is not readily apparent to someone familiar
with the basic stock of common knowledge and techniques for the area
concerned
? Systematic Approach
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
23. Research and development
Appreciable
element of
novelty
Eligible R&D
? Resolution of
Systematic scientific
approach and/or
technological
uncertainty
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 23
24. Research and development
Other criterions for distinguishing R&D from related activities are
? What are the objectives of the project?
? What is new or innovative about this project?
? Is it seeking previously undiscovered phenomena, structures or
relationships?
? Does it apply knowledge or techniques in a new way?
? Is there a significant chance that it will result in new (extended or deeper)
understanding of phenomena, relationships or manipulative principles of
interest to more than one organization?
? Are the results expected to be patentable?
? What staff is working on the project?
? How general are the findings or results of the project likely to be?
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
25. Research and development
Objective of the project
A particular project may be R&D if undertaken for one reason, but not if
carried out for another, as shown in the following examples:
? In the field of medicine, routine autopsy on the causes of death is the
practice of medical care and is not R&D; special investigation of a
particular mortality to establish the side effects of certain cancer
treatments is R&D
? Similarly, routine tests such as blood and bacteriological tests carried out
for doctors are not R&D, whereas a special programme of blood tests in
connection with the introduction of a new drug is R&D
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
26. Research and development
Excluded activities
Education and training
Other related scientific and technological activities
? Scientific and technical information services
? General purpose data collection
? Testing and standardisation
? Feasibility studies
Other industrial activities
? Scientific, technical, commercial and financial steps necessary for the
implementation of new or improved products or services
Administration and other supporting activities
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti
27. Research and development
Instructions of the Czech Ministry of Finance D 288
Eligible R&D activities in the Czech Republic
? Medical and pharmaceutical research
? Medical and Pharmaceutical Development
? Clinical trials for drugs, vaccines or treatments but only to grant
permission to manufacture.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 27
28. Research and development
Clinical trials
Before new drugs, vaccines or treatments can be
introduced on the market, they must be tested
systematically on human volunteers to ensure that they
are both safe and effective
? Divided into four standard phases, three of which take place before permission to
manufacture is accorded
? Clinical trial phases 1, 2 and 3 can be treated as R&D
? Phase 4 clinical trials, which continue testing the drug or treatment after approval
and manufacture, should only be treated as R&D if they bring about a further
scientific or technological advance
? Not all activities undertaken prior to permission to manufacture are considered to be
R&D, especially when there is a significant wait after the completion of phase 3
trials
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 28
29. Pharmacy and Clinical Services
Arjaan MUNTSLAG
Senior International Innovation Consultant
30. Pharmacy and clinical services
Typical scientific and technological activities
? Developing production processes for new products, including official public
qualification, validation, and clinical testing during Phases I-IV clinical trials
? Establishing a new factory or production line where new technology is
employed or new manufacturing techniques are used
? Manufacturing experimental qualification lots and clinical trial lots
? Manufacturing process scale-up design and development efforts
? Creating cross-functional process improvement teams, including
production and maintenance employee activities as well as continuous
improvement initiatives
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 30
31. Pharmacy and clinical services
Typical scientific and technological activities (continued)
? Developing technology for compliance with national requirements and
environmental regulations
? Developing new product and process test methodology
? Designing and developing certain hardware and software systems
(Clinical Trial Management Systems - CTMS) for use in research and
clinical development, and medical device equipment used for treating
various diseases
? Developing product improvements to increase the shelf life or stability of
an existing product and reformulation to reduce side effects or dosage
? Supporting new or improved product development through
pharmacovigilance data collection activities and biometrics analyses
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 31
32. Pharmacy and clinical services
Eligible R&D activities in the sector of clinical services
Focus on clinical trials
? Phases up to III are mostly eligible
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 32
33. Pharmacy and clinical services
Specific difficulties for clinical trials
? Creating the test protocol is very complex
? Trial design (randomized, double blind, and placebo-controlled)
? How to calculate the number of patients (statistics and drug impact)?
? What approach and method (age, type of illness for patients)?
? How to compare results with placebo or existing medicine?
? Evaluating interactions with other patient specific medicine, genetics
or way of life that might impact results
? Scientific knowledge is often inaccessible as it is protected by patents or
not public
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 33
34. Pharmacy and clinical services
Case study
BELGIAN company XXXXX
? New product development using an API (Active Pharmaceutical Ingredient) to treat
a rare illness (type of cancer)
? Pre-formulations to determine the properties of the API
? Development of ways of stabilising the product and creating dosage forms
? Slow release of the product; simulating the best dosage forms
? Researching the best way to store (pens, cartridges, pre-filled
syringe/injections)
? Up-scaling technologies
? Difficulties: stabilising the molecules, respecting GMP standards, stability of the API
to light, to oxygen, volatile API.
V. konference Rizika v ?innostech farmaceutick¨¦ spole?nosti 34
